New EU Regulation and Streamlined Acceptance Procedures for Testing Methods

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New EU Regulation and Streamlined Acceptance Procedures for Testing Methods

Published: May 28, 2008
On 22 May 2008, the European Parliament endorsed, by overwhelming majority, a resolution chastising EU regulators for moving too slowly to accept 3Rs methods that have been endorsed as scientifically valid by the ECVAM Scientific Advisory Committee (ESAC), and calling for significant changes to European Commission internal procedures to accelerate the acceptance of non-animal tests in the future, with increased transparency and stakeholder involvement.

The move came in response to concerns raised by the EU office of Humane Society International that a new regulation proposed by the European Commission––which will replace the list of EU-recognized tests for human health, ecological and other effects currently codified in Annex V of the EU 1967 Dangerous Substances Directive––contains obsolete animal tests that should be deleted, and overlooks a number of validated and ESAC-endorsed methods that replace or reduce animal use. In so doing, the draft regulation fails to satisfy either the requirements of Article 7.2 of Directive 86/609/EEC, which requires that non-animal methods be used whenever reasonably and practicably available, or Article 13 of Regulation (EC) No 1907/2006 (REACH), which stipulates that adoption of alternative, non-animal test methods should take place “as soon as possible.”

In April 2008, the Parliament launched a legal procedure to reject the proposed test methods regulation unless the Commission demonstrated substantive effort to remove barriers to the regulatory acceptance of validated 3Rs methods. This decisive political move prompted a recent commitment by Commission services to implement more streamlined and transparent procedures for EU acceptance of alternative test methods for regulatory purposes.

In a letter to the Parliament’s Environment Committee, Commissioners Günter Verheugen (Enterprise and Industry), Janez Potočnik (Science and Research) and Stavros Dimas (Environment) promised to implement the following substantive changes to current EU processes:

  • Introduction of a “preliminary analysis of regulatory relevance” to ensure that validation efforts focus on test methods that have the greatest potential to be considered suitable for clearly identified regulatory purposes
  • Reduction in the number of steps in the EU regulatory acceptance process, and establishment of new and clear deadlines to streamline and accelerate current processes
  • Provision that important procedural decisions by the Commission will be taken at the highest (Directorate General) level
  • Reorganization of the JRC Institute for Health and Consumer Protection, which houses ECVAM
  • Increased transparency at all levels

The Commissioners also acknowledged the slow pace of progress in the OECD Test Guidelines Programme, and further committed to doing everything in its power to improve the efficiency of the regulatory acceptance process internationally as well.

In light of the above commitments, the European Parliament resolved on May 22 not to oppose adoption of the Commission test methods regulation, provided:

  • The streamlining and acceleration of internal procedures applies to the entire process from validation to regulatory acceptance with no gaps
  • The Commission ensures full stakeholder participation throughout the process from validation to regulatory approval
  • The Commission comes forward with a proposal for the first adaptation to technical progress of this Regulation by the end of 2008 “as the litmus test for the implementation of the above commitments”
  • The Commission reports to the Parliament by the end of 2008 about the implementation of the above commitments